Prevalence of Anal Sphincter Defects After Childbirth (PRADA)

Prevalence of Anal Sphincter Defects After Childbirth in Primiparous Women

The incidence of obstetric sphincter tears has risen to 15-30% and the prevalence of anal incontinence (AI) symptoms after childbirth may be as high as 40%. The present study aims to evaluate the prevalence of anal sphincter defects after childbirth in primiparous women-

Study Overview

• Status: Not yet recruiting
• Conditions: Fecal Incontinence; Childbirth Problems
• Intervention / Treatment: Other: Endoanal Ultrasound (EAUS)

Detailed Description

The incidence of sphincter defect in women has raised in recently with current rates as high as 30% after vaginal deliveries. Fecal incontinence could be present at the time of the delivery but it is a real problem longtime after, in women older than 60 years.

It is of great importance not only an early detection but to indicates the best possible management as soon as posible.

The design is a prospective observational study including primiparous woman, without previous anal surgery.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jose-M Ramirez, Prof; Phone Number: +34639776364; Email: jramirez@unizar.es

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Hospital Clinico Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primaparous pregnat

Description

Inclusion Criteria:

• Primiparous pregnant patients aged >18 y, evaluated during pregnancy and after childbirth, including both vaginal and cesarean deliveries.

Exclusion Criteria:

• Non primiparous patients and patients with a history of anal surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EAUS; Patients with EAUS pre and postpartum	Other: Endoanal Ultrasound (EAUS); Endoanal Ultrasound pre- and postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Integrity of anal sphincter	No defect detected on EAUS	4 months
Defects on anal canal	Disruption of any of the anal canal sphincters	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL	According to a dedicated questionnaire	4 months

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Collaborators: Instituto de Investigación Sanitaria Aragón; Hospital Clínico Universitario Lozano Blesa
• Investigators: Principal Investigator: Jose-M Ramirez, Prof, Universidad de Zaragoza

Publications and helpful links

General Publications

• Tejedor P, Plaza J, Bodega-Quiroga I, Ortega-Lopez M, Garcia-Olmo D, Pastor C. The Role of Three-Dimensional Endoanal Ultrasound on Diagnosis and Classification of Sphincter Defects After Childbirth. J Surg Res. 2019 Dec;244:382-388. doi: 10.1016/j.jss.2019.06.080. Epub 2019 Jul 17.
• Harvey MA, Pierce M, Alter JE, Chou Q, Diamond P, Epp A, Geoffrion R, Harvey MA, Larochelle A, Maslow K, Neustaedter G, Pascali D, Pierce M, Schulz J, Wilkie D, Sultan A, Thakar R; Society of Obstetricians and Gynaecologists of Canada. Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair. J Obstet Gynaecol Can. 2015 Dec;37(12):1131-48. doi: 10.1016/s1701-2163(16)30081-0. Erratum In: J Obstet Gynaecol Can. 2016 Apr;38(4):421. J Obstet Gynaecol Can. 2016 Apr;38(4):421.
• Thomas GP, Gould LE, Casunuran F, Kumar DA. A retrospective review of 1495 patients with obstetric anal sphincter injuries referred for assessment of function and endoanal ultrasonography. Int J Colorectal Dis. 2017 Sep;32(9):1321-1325. doi: 10.1007/s00384-017-2851-3. Epub 2017 Jul 7.
• Sultan AH, Thakar R. Diagnosis of anal sphincter tears to prevent fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1108-9; author reply 1109. doi: 10.1097/01.AOG.0000186051.88740.7f. No abstract available.
• Johannessen HH, Wibe A, Stordahl A, Sandvik L, Morkved S. Do pelvic floor muscle exercises reduce postpartum anal incontinence? A randomised controlled trial. BJOG. 2017 Mar;124(4):686-694. doi: 10.1111/1471-0528.14145. Epub 2016 Jun 7.
• Damon H, Bretones S, Henry L, Mellier G, Mion F. Long-term consequences of first vaginal delivery-induced anal sphincter defect. Dis Colon Rectum. 2005 Sep;48(9):1772-6. doi: 10.1007/s10350-005-0075-z.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Childbirth; Fecal Incontinence; Anal Ultrasound
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: UZaragoza-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No